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3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages

Study acronym: 3D-TRUBI
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated March 20, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoints revised (2)
    • Secondary endpoints: 1 to 2
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of this study is to assess the safety of the 3D Transcranial Ultrasound Brain Imaging (3D TRUBI) device in Traumatic Brain Injury (TBI) patients with intracranial hemorrhage (ICH). The secondary objective is to assess the diagnostic potential of 3D TRUBI. The latter will be achieved by comparison of 3D TRUBI scans with admission head computed tomography (CT), the standard of care diagnostic modality. Demonstrating the feasibility and safety of the 3D TRUBI system is the first step toward expanding access of an alternative to CT for diagnostic imaging and triage of mass casualties of war or natural disasters in the field and in rapidly deployed medical centers or other austere environments.
Trial Details
NCT Number NCT06780436
Lead Sponsor The Geneva Foundation
Collaborators: Brooke Army Medical Center, Uniformed Services University of the Health Sciences
Conditions
(from sponsor)		 Traumatic Brain Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhages, Ultrasound Exams, 3D SONOGRAPHY
Related terms Brain Hemorrhage, Traumatic, Brain Injuries, Traumatic, Intracranial Hemorrhages
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov